Eflapegrastim-xnst - Biologic Drug Details

Summary for eflapegrastim-xnst

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for eflapegrastim-xnst

Physiological Effect	Increased Myeloid Cell Production
Established Pharmacologic Class	Leukocyte Growth Factor
Chemical Structure	Granulocyte Colony-Stimulating Factor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for eflapegrastim-xnst Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for eflapegrastim-xnst Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for eflapegrastim-xnst Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Eflapegrastim-xnst (ROLVEDON)

Introduction

Eflapegrastim-xnst, marketed as ROLVEDON, is a novel long-acting recombinant human granulocyte-colony stimulating factor (G-CSF) approved by the FDA for the decrease of the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. Here, we delve into the market dynamics and financial trajectory of this biologic drug.

Market Context: Biologics and Biosimilars

Biologics have become a significant segment of the pharmaceutical market, growing from 30% of the total medicines market in 2014 to 42% by 2019. This growth is driven by their efficacy in treating complex diseases and their high market value[3].

Approval and Clinical Trials

ROLVEDON was approved by the FDA based on data from the phase 3 ADVANCE and RECOVER trials, which demonstrated its non-inferiority to pegfilgrastim (Neulasta) in reducing the incidence and duration of severe neutropenia in patients with breast cancer receiving docetaxel and cyclophosphamide chemotherapy. These trials showed a clinically meaningful reduction in severe neutropenia, with an 8.5% absolute and a 34.9% relative risk reduction compared to pegfilgrastim[2].

Market Positioning

ROLVEDON enters a competitive market dominated by established G-CSF products like pegfilgrastim. However, its approval marks a significant milestone for Spectrum Pharmaceuticals, transforming the company into a commercial-stage entity competing in a $2 billion market. The drug offers a unique value proposition, particularly in the community oncology and hospital segments[2].

Target Market

The initial launch strategy for ROLVEDON focused on community oncology, 340B, and non-340B hospitals. By the end of the first quarter of its launch, 70 targeted accounts had purchased ROLVEDON, including the top three community oncology networks, which represent approximately 22% of the total clinic market[1].

Financial Performance

Initial Sales and Revenue

Preliminary unaudited net sales for ROLVEDON in the fourth quarter of 2022 were approximately $10 million. For the full year, Spectrum Pharmaceuticals reported $10.1 million in sales, marking a promising start in the U.S. market[1][4].

Cash and Financial Resources

As of December 31, 2022, Spectrum Pharmaceuticals had $75 million in cash, cash equivalents, and marketable securities, which is expected to extend the company's cash runway through 2024. This financial stability is crucial for the ongoing commercialization and development of ROLVEDON[1].

Cost and Pricing Strategy

The cost-effectiveness of ROLVEDON is a key factor in its market positioning. Studies have shown that biosimilars and novel G-CSFs like eflapegrastim can offer comparable efficacy and safety to established products at potentially lower costs. This makes ROLVEDON an attractive option for clinics and hospitals looking to manage costs while maintaining treatment efficacy[4].

Research and Development

Spectrum Pharmaceuticals has been focusing on optimizing its R&D expenses, particularly after the approval and launch of ROLVEDON. The company reduced its workforce by 75% to conserve resources, with a significant portion of the R&D budget now dedicated to supporting the commercial success of ROLVEDON. Additional studies, such as the phase 4 clinical trial (NEUTHREE), are underway to further establish the drug's efficacy and safety profile[4].

Regulatory Recognition

ROLVEDON has been included in the latest National Comprehensive Cancer Network® (NCCN) Supportive Care Guidelines for Hematopoietic Growth Factors, which provides recommendations for the management of febrile neutropenia. This inclusion enhances the drug's credibility and acceptance within the medical community[4].

Future Outlook

The market for G-CSFs is expected to remain competitive, with biosimilars and new entrants vying for market share. However, ROLVEDON's unique value proposition, supported by robust clinical data, positions it well for long-term success. As the drug continues to gain traction in the market, Spectrum Pharmaceuticals is committed to disciplined execution of its launch strategy to establish a strong market presence.

Competitive Landscape

The biologics market, particularly for G-CSFs, is subject to increasing competition from biosimilars. By 2019, 17% of the biologics market was accessible to biosimilars, and this percentage is expected to grow. ROLVEDON must navigate this competitive landscape by emphasizing its efficacy, safety, and cost-effectiveness[3].

Key Takeaways

• Approval and Clinical Trials: ROLVEDON was approved based on phase 3 trials demonstrating non-inferiority to pegfilgrastim.
• Market Positioning: Targets community oncology, 340B, and non-340B hospitals with a unique value proposition.
• Financial Performance: Initial sales of $10 million in Q4 2022 and $10.1 million for the full year; $75 million in cash and financial resources.
• Cost and Pricing Strategy: Emphasizes cost-effectiveness and comparable efficacy to established products.
• Research and Development: Focused on supporting ROLVEDON's commercial success with ongoing studies.
• Regulatory Recognition: Included in NCCN Supportive Care Guidelines.

FAQs

What is ROLVEDON (eflapegrastim-xnst), and what is it used for?

ROLVEDON is a long-acting recombinant human G-CSF used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

What were the key findings of the ADVANCE and RECOVER trials?

The trials showed that ROLVEDON was non-inferior to pegfilgrastim in reducing the incidence and duration of severe neutropenia in breast cancer patients receiving docetaxel and cyclophosphamide chemotherapy.

How much did Spectrum Pharmaceuticals generate in sales for ROLVEDON in its first year?

Spectrum Pharmaceuticals reported $10.1 million in sales for ROLVEDON in its first year of release in the U.S. market.

What is the current cash position of Spectrum Pharmaceuticals?

As of December 31, 2022, Spectrum Pharmaceuticals had $75 million in cash, cash equivalents, and marketable securities.

Is ROLVEDON included in any clinical guidelines?

Yes, ROLVEDON has been included in the latest National Comprehensive Cancer Network® (NCCN) Supportive Care Guidelines for Hematopoietic Growth Factors.

Sources

1. Spectrum Pharmaceuticals Provides Update on ROLVEDON™ (eflapegrastim-xnst) Injection and Announces Unaudited Fourth Quarter 2022 Financial Results. Biospace.
2. FDA Approves Eflapegrastim for Chemo-Induced Neutropenia. Onclive.
3. Biologics Market Dynamics: Setting the Stage for Biosimilars. FTC.
4. Rolvedon (eflapegrastim-xnst) / Hanmi, Assertio. LARVOL DELTA.

Last updated: 2024-12-22